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ISO TR 10993-33 : 2015

M00022577

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ISO TR 10993-33 : 2015

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 33: GUIDANCE ON TESTS TO EVALUATE GENOTOXICITY - SUPPLEMENT TO ISO 10993-3

International Organization for Standardization

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Table of Contents

Foreword
Introduction
1 Scope
2 Selection of tests
3 Recommended tests
4 Use of in vitro tests to detect genotoxicity
5 Use of in vivo tests to detect genotoxicity
6 Bacterial reverse mutation assay
7 In vitro mammalian chromosome aberration test
8 In vitro mammalian micronucleus test
9 In vitro mammalian cell gene mutation test using
   mouse lymphoma (L5178Y) cells
10 In vivo mammalian erythrocyte micronucleus test
11 Chromosome aberration test (in vivo)
Bibliography

Abstract

Describes the views of regulatory bodies on the subject of genotoxicity testing.

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 194